Many patients, due to various medical conditions, have undergone diversionary colostomy procedures. A colostomy is a surgical creation of an artificial anus in the abdominal wall by incising the colon and then extending it to the surface. The stoma is the end of the small bowel extending through the abdomen. Colostomies are often performed because of cancer or benign, obstructive tumors or severe abdominal wounds. Many colostomates establish a regular schedule with proper care, colostomy irrigation and a proper pouching system.
However, even with proper surgery and post-surgical care, colostomates may suffer incontinence and lack the control over gas and feces that the normal rectal sphincter affords.
Accordingly, there exists a need for a device used by colostomy patients alerting the patient to an impending episode and also creating an obstacle or barrier to the passage of fecal matter. Review of the existing published art indicates there are various devices and methods for the detection, indication and prevention of such incontinent episodes.
U.S. Pat. No. 4,813,422 relates to a bowel control probe apparatus and method for sensing and preventing incontinent episodes. The probe comprises a catheter with an IP sensor tip for sensing fecal mass in the rectum and a cuff which is inflated with air to prevent passage of the fecal mass. The method of sensing and preventing incontinent episodes includes inserting the probe in the rectum, inflating the cuff, transmittion IR light into the rectum, monitoring the reflective IR light and generating an alarm signal when a predetermined amount of reflective IR is measured.
European Patent Application No. 88303054.6 also discloses a probe insertable into the colon having a sensor element at the tip and a light transmissive element. The sensor reflects light transmitted in response to the presence of fecal matter. The probe is preferably two-piece having a disposable section for insertion, inflatable cuff is provided to block the colon. Vent ports may be provided.
The preceding two patents relate to devices and methods for monitoring fecal mass in the colon. The patent literature also suggest other types of devices for use by colostomy patients. U.S. Pat. No. 4,351,322 relates to a stoma-control device and method including a support ring for surgical implantation in the body beneath the abdominal wall extending substantially around the stoma. The support is formed of a soft material and tapers outwardly to a large supporting surface for the bowel. A plug is adapted to be received in the stoma within the bowel for controlling the stoma. The plug includes an inflatable balloon which, when inflated, presents an outwardly tapered surface with a shape complimenting the tapered inner surface of the support.
U.S. Pat. No. 6,171,289 relates to a disposable device for securing a colostomy bag to a stoma which has an adhesive seal which is applied on the patient by means of a contact face. A through passage communicates with the stoma. A wetness detection device comprising at least two series of electrodes for measuring conductivity are provided to trigger an alarm when a predeteremined level of wetness is reached.
Thus, from the foregoing, it will be seen there are various approaches to providing comfort to individuals having bowel incontinence which includes use of optical wetness sensors. In the case of colostomy patients, the existing art suggests insertable devices including an inflatable element for blocking fecal matter. However, there nevertheless exists a need for a colostomy alert device which is comfortable and which will provide an obstacle to passage of fecal matter and which device does not require surgical implantation. There also exists a need for a device which will provide the user an indication of an impending episode so that the patient may, by having advance notification, take appropriate action to avoid any unpleasant and embarrassing incontinent episodes. In case of an ambulatory patient, the individual may remove himself or herself to a bathroom. In the case of a bedridden patient, the individual can summon a medical attendant prior to elimination so the individual may be assisted in reaching toilet facilities. Thus, elimination can be controlled in a manner which avoids both embarrassment and the soiling of clothing and bed linens.